Medline Syringe Kits Recall for Unapproved Design Changes
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Medline Industries is recalling 270,311 units of certain convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes outside of 510(k) clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Medline Industries, LP is recalling certain convenience kits because of unapproved design changes to the products that were made outside of the required 510(k) clearance.
Which Products Are Affected
The affected products are Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, specifically: MINOR ENT SINUS PACK-LF with SKUs DYNJ0101278F, DYNJ0101278G, and DYNJ0101278I; and SINUS PACK with SKU DYNJ56262. The total quantity affected is 270,311 units. Specific code information includes: DYNJ0101278F with UDI-DI 10193489352351 (EA) and 40193489352352 (CS), lots 22CDB133, 22EDA975, 22FDA831, 22HDC403; DYNJ0101278G with UDI-DI 10195327286477 (EA) and 40195327286478 (CS), lots 22KDB109, 22LDA476, 23CDA805, 23DDB546, 23EDC278, 23FDC023, 23JDA625, 23KDB893, 24ADB642, 24BDB842, 24CDB908, 24GDA043, 24IDA026; DYNJ0101278I with UDI-DI 10198459119477 (EA) and 40198459119478 (CS), lot 24JDC169; and DYNJ56262 with UDI-DI 10889942624331 (EA) and 40889942624332 (CS), lot 24ABO125. The distribution was nationwide in the United States and also to Canada, Panama, and Barbados.
What You Should Do
Consumers who have these products should follow the initial firm notification, which was issued via letter, and contact Medline Industries, LP for further instructions on returns or refunds. The recalling firm is located at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall addresses potential safety concerns from unapproved changes in medical devices, which could affect product performance and user safety in healthcare settings.
Source
This information is from the FDA recall announcement, recall number Z-1880-2026.
Original source: FDA Official Notice ↗
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,693 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.